Determining Best Indications for Bracing for Adolescent Idiopathic Scoliosis
ConditionAdolescent Idiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-18
SponsorThe University of Hong Kong
About this trial
This is a prospective study for Investigating the cost-effectiveness of current bracing protocols for adolescent idiopathic scoliosis (AIS). It is hypothesized that aggressive management of adolescent idiopathic scoliosis (AIS) including early bracing at mild curve magnitudes and surgery at 40 degrees is more cost-effective while maintaining similar health quality of life. Scoliosis Research Society 22-item and EuroQol- 5 dimension questionnaires and direct/indirect medical costs will be utilized for the cost-effectiveness analysis and health related quality of life assessment. The findings of this study have the potential to improve decision-making and revolutionize care of AIS patients in Hong Kong and globally. Clinicians will be able to utilize our results to provide the best and most cost-effective timing for initiating brace treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are diagnosed with adolescent idiopathic scoliosis and are seen in the first setting with remaining growth potential (Risser 0-2), and are prescribed with either underarm (Boston) or Milwaukee bracing
Disqualifiers
Patients whose diagnosis is not adolescent idiopathic scoliosis, unable to comply with study follow-up and refused consent for study
Trial population
This is a prospective cohort of AIS patients who are newly prescribed with bracing treatment
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Bracing
Other intervention
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: Bracing AIS patients1 intervention
Trial outcomes
Primary outcomes
1
Change in Cobb angle
Cobb angle changes from final visit as compared to baseline
Time frame
up to 3 years2
Cost-effectiveness of bracing - direct and indirect costs
Costs involve number of clinic follow-up, any form of outpatient and inpatient treatment (including physiotherapy, scoliosis specific exercises, bracing) and complications. Unit cost of investigation, treatment and follow-up. These will be analyzed against the benefits of bracing on clinical parameters, that is, any deterioration of Cobb angle
Time frame
up to 3 years3
Change in C7-CSVL
Changes in C7-central sacral vertical line with brace follow-up
Time frame
up to 3 years4
Change in truncal shift
Changes in truncal shift with brace follow-up
Time frame
up to 3 yearsSecondary outcomes
1
Patient's quality of life - SRS-22r
Using the refined Chinese version of the Scoliosis Research Society-22 (SRS-22r) questionnaire scores changes of total score and domain scores (Domains: Activity, Self-image, Pain, Mental Health, Satisfaction with Treatment). The highest score is 5 for total score and each domain score. The higher the score, the better the patient's quality of life is. Total
Time frame
up to 3 years2
Patient's quality of life - EQ5DY
Using the changes of EQ5DY scores (total score and dimension scores: Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and EQ-visual analogue scale (EQ-VAS)). Each dimension has 5 levels of response and each response will provide one digit to represent it. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. These health states can be converted into a single index value by using the standard EQ-value sets for the local population. For the EQ-VAS, it is a patient's perception of own general health status on a scale from 0 to 100, with higher the score, the better the status.
Time frame
up to 3 years3
Brace compliance
Thermal sensor objective compliance data
Time frame
up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov